by Ann Zaniewski, Detroit Free Press

by Ann Zaniewski, Detroit Free Press

DETROIT -- William Wertz wonders whether the fungus will attack his body again - and what it would feel like to die.

"If I have fungal meningitis, how would my body shut down?" said the 68-year-old Howell man. "(Would I be) in a lot of pain, or would I go to sleep? Would I be like a dementia patient?

"They told me there's no guarantee that it's not going to be back."

Wertz is among the hundreds of patients devastated by a deadly national fungal meningitis outbreak that exploded last fall and was caused by steroid injections that came tainted with fungus from a Massachusetts pharmacy.

One year later, people are still suffering health problems linked to both the tainted shots and the powerful antifungal medicine they took to save their lives. Most are off the drugs, but some are back in the hospital.

Investigations and litigation connected to the outbreak are ongoing, as are efforts to strengthen regulation of the type of pharmacy responsible for the crisis. Health experts say more people could fall ill.

For patients, questions still linger: How did this happen? Why were some toxic shots injected after being recalled? Will I get sick again?

Fungus just the start

Michigan remains the hardest hit state in the outbreak, according to the most recent case counts from the Centers for Disease Control and Prevention. The shots sickened 264 people in the state. Nineteen have died, not including three Michigan residents whose deaths figure into Indiana's case count because that's where they got their shots.

Nationwide, there have been 750 illnesses reported and 64 deaths.

Wertz got meningitis and then an infection at the injection site from the shot he took to relieve thigh pain. He was hospitalized twice last fall at St. Joseph Mercy Ann Arbor. The hospital has treated 195 people sickened in the outbreak, more than any other facility in the country.

Today, about two-thirds of those patients are off antifungal drugs but still being monitored, said Dr. David Vandenberg, medical director of clinical outcomes management at the hospital. Another 25% with the most serious infections had yearlong treatment plans to begin with and are still on antifungal medicine.

About a dozen people have responded poorly to treatment or relapsed.

"None of us have ever seen a public health crisis that had this kind of a course, where it came on rapidly but sustained for this long," Vandenberg said. "I don't think we're in any position yet to say anybody whose been diagnosed and treated for this is in the clear."

The main fungus associated with the outbreak, Exserohilum rostratum, grows slowly and has caused diseases that are difficult to treat.

Donald Hixson, 68, of Pinckney was hospitalized for six days for meningitis and another time for 32 days because of an abscess at the injection site on his back. He had two surgeries. The antifungal medicine pumped through his IV caused kidney problems and strange hallucinations.

The retired toolmaker finally got off antifungal pills in June, but peculiar ailments remain - pimples on his face, hair that's fallen off his arms, armpits and legs, increased irritability and trouble with his balance. He also struggles with back pain and faces new physical limitations.

"I feel as if it's taken a year of quality away from my life," Hixson said. "I know others have died of it, so I have to count my blessings that I'm still here above ground. But I don't have a normal life anymore."

Recalled shots given

The outbreak began to unfold in late summer 2012 in Tennessee when a doctor discovered fungus in the spinal fluid of a sick man who had previously gotten epidural steroid injections. She alerted the Tennessee Department of Health on Sept. 18, 2012, sparking an investigation that would spread across the country and link back to one place - the New England Compounding Center in Massachusetts.

The company had shipped 17,000 vials of the tainted steroid, preservative-free methylprednisolone acetate, to facilities in 23 states.

On Sept. 26, 2012, just after the NECC voluntarily recalled the steroid, inspectors found dirty equipment and other "serious health and safety deficiencies" at the pharmacy. But in Michigan, some patients were still being poisoned.

Wertz and Hixson say they were injected that Oct. 2 at Michigan Pain Specialists, a Brighton clinic they and other patients are suing in Livingston County Circuit Court.

Robert Sickels, a Southfield attorney representing them, said the NECC faxed recall notices to clinics Sept. 26. But, Sickels said, attorneys for Michigan Pain Specialists have told him that the clinic wasn't initially contacted by the NECC.

"We're in the process of trying to determine whether that's true, or whether, due to some negligence on their part, they did not properly understand the communication, or whether due to some negligence, they didn't actually receive it," Sickels said in late August. "Maybe a fax was received by some personnel and put in a drawer. We don't know.

"We do know that virtually every clinic that bought products around the country received a fax notice from NECC," Sickels said. "For (some) reason, according to MPS, they did not."

Randy Hackney, an attorney representing Michigan Pain Specialists, declined to comment. In court documents filed in response to the lawsuits, the clinic said it denies allegations of negligence and malpractice.

Another state facility, the Michigan Neurosurgical Institute, learned about the potential link between the steroids and meningitis when the Michigan Department of Community Health called Oct. 3, according to a spokeswoman.

Some of the state lawsuits allege that Michigan Pain Specialists injected people with methylprednisolone acetate from the NECC but billed for Depo-Medrol, a name-brand version of drug made by Pfizer and regulated by the FDA.

The lawsuits also take aim at the clinic's practice of buying the steroid in bulk from the NECC without submitting individual patient prescriptions.

Traditional pharmacy compounding involves a pharmacist modifying drugs to suit an individual patient's needs based on a prescription. Officials say the NECC was violating state regulations by operating more like a big drug manufacturer, distributing large amounts of products for general use instead of requiring individual prescriptions.

Hundreds of lawsuits have been filed nationally in connection with the outbreak. Federal court cases have been consolidated as part of multi-district litigation before a U.S. District Court judge in Boston.

Investigations begin

In late September 2012, the CDC sent alerts to health agencies about the burgeoning crisis.

Jay Fiedler, the MDCH's section manager of Surveillance and Infectious Disease Epidemiology, told the Free Press earlier this year that state health officials learned Oct. 2 the names of the four Michigan clinics that received tainted steroids. Staff at the clinics and state officials spent the next few days frantically trying to contact affected patients.

But some people were still in the dark. Peggy Nuerenberg of Williamston said she didn't know her sick mother had gotten a tainted shot until she called Michigan Pain Specialists on Oct. 12. In less than a month, her mom would be dead.

Another patient at the Brighton clinic has alleged, according to court documents, that he didn't find out he may have gotten a bad shot until Oct. 28.

Various state and federal agencies have launched investigations. In April, the Michigan Court of Appeals granted state Attorney General Bill Schuette's request to empanel a grand jury to investigate the outbreak. Schuette and state Rep. Joe Hune, R-Hamburg Township, recently announced legislation to strengthen pharmacy regulation in Michigan.

And late last month, members of U.S. Senate and House committees agreed on proposed legislation aimed at preventing a similar public health crisis. Compounding pharmacies that voluntarily register as outsourcing facilities would be subject to Food and Drug Administration oversight in a similar way as drug manufacturers. Currently, the FDA licenses drug manufacturers but not compounding pharmacies, leaving it primarily up to states to monitor them.

The legislation, which the House passed Sept. 28, also would establish a uniform pharmaceutical tracking system.

Something felt wrong

Nuerenberg's 88-year-old mother, Mary Plettl, had gotten steroid shots before. But after a visit in August 2012 to Michigan Pain Specialists, she told her daughter something felt "drastically wrong."

Nuerenberg called 911 days later because her spunky, independent mother - who liked watching sports and top-shelf margaritas - was weak, having trouble breathing and in terrible pain. A trip to a hospital yielded no answers, so she was sent to a rehabilitation facility.

Plettl - unaware of the fungus growing inside her - was convinced her health would improve if she worked harder at physical therapy. But she was dying.

"She just kept saying, 'I just need to really work harder on my rehab and do my exercises,'" Nuerenberg said. "This is a woman who was so sick, and every day she tried so hard. Her goal was to get better."

Nearly one year after losing her mother, Nuerenberg remains overwhelmed by grief.

"I think of how I dropped her off in the circle drive in front of the clinic that day and she got out of the car on her own, opened the door of the clinic and went to the office," Nuerenberg said. "I also think now of watching her walk out after I brought the car around, (having) no clue that they had just put mold into her."

Nuerenberg worries that the crisis is "hardly a blip on anyone's radar."

"Anyone who expects to get an injection sometime during the rest of their life should really care about what happened here,"she said.